This invention relates to a method and apparatus for recording the measurements which varies with time, together with time measurement data, in various clinical tests and storing the test data at the same time as the measurement to understand the conditions of the patient from the aspect of variation, and method of controlling and processing the test data.
At present, clinical test techniques using various analytical apparatus and reagents for discovery and diagnosis of diseases, ascertaining the medical effect, and monitoring the morbidity change are established and widely applied to many diseases. However, these clinical tests must normally be carried out in medical institutions since they generally require sophisticated techniques and knowledge and the judgment based on the test results require expert knowledge.
On the other hand, ascertaining the medical effect and monitoring the morbidity change require continual measurement. When a long period home treatment is required, regularly going to the hospital is a burden, the patient, physically mentally and economically and neglecting the test can cause problems such as worsening morbidity. The fundamentals of the diabetes remedy, for example, are alimentotherapy, exercise cure, and medical therapy, and, in particular, it is a large problem for a insulin-dependent diabetes patient or a diabetes pregnant woman to control the blood sugar level in a proper range. For this reason the patient has to go to hospital regularly to receive instructions from the doctor while while paying attention to the daily diet.
To solve such inconvenience, a control technique called "home monitoring" or "self monitoring" is being tentatively adopted recently, in which the patient himself performs the various tests using an analytical implement or measuring instrument provided with a simplified measuring reagent (solid reagent) which can be used simply by even a layman. The patient records the measurements on memo paper or the like and reports them later collectively to the doctor for his (and the patient's) inspection of the variation for ascertaining the therapeutical effect, monitoring morbidity change, and for new instructions to the patient. This technique, which can be practiced at home, makes frequent measurement possible and elevates the patient's sense of participation, resulting in a large effect of correct self control in daily life. The solid reagent mentioned here includes a carrier such as paper impregnated with a reagent and film formed of a mixed reagent and polymeric material. The solid reagent is fixed to a strip or piece-shaped backing for convenience to form an analytical implement.
However, in the home monitoring practiced so far, the record by the patient, which is reported to the doctor at the next visit to hospital, is apt to contain errors caused when it is copied for reporting, and copying itself is very troublesome. In addition, a continuous change is difficult to make out unless it is shown graphically, and making a graph requires much trouble. This, together with the copying, limits the number of patients a doctor can deal with. Thus, the home monitoring has many difficulties in practice, though being an excellent technique. Among these difficulties, copying errors and troublesomeness in the patient side and data processing in the doctor side are large problems. Further, accurate recording and copying of the time, quantity, and degree of external action to the patient such as medication and injection, which are important factors, are also troublesome and apt to produce error.